MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC PLUS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E200-29M

Device Problems Incomplete Coaptation (2507); Central Regurgitation (4068)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/28/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2022, a 29mm epic plus valve was successfully implanted.An echocardiogram was performed post procedure showed a large amount of regurgitation.The valve was then removed and replaced with a 31mm epic plus valve.The patient was reported as recovering.

Manufacturer Narrative

An event of an unusual central hole seen in the valve and moderate to severe regurgitation was reported.The device was returned to abbott for investigation.The investigation found that the sewing cuff was be fully intact and all leaflets were mobile.The valve was sent for functional testing at the engineering test lab.Functional testing revealed leaflet function was considered abnormal as one of the leaflets appeared to be co-apting low along with an apparent central jet.However functional testing at the time of manufacturing indicated the valve functioned normally.This test ensures proper cuspal coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications, including inspection for proper coaptation.Information retrieved from device history record indicates that it was approved at coaptation visual inspection performed at hydrodynamic test at moment of manufacturing.The hydrodynamic characteristics of the epic tissue heart valve were tested within the manufacturing process through pressure gradient measurement and coaptation visual inspection performed at steady flow tester.The cause of the reported event could not be conclusively determined, however it is possible the valve structure was damaged during implant or explant of the valve, which could have impacted the coaptation of the leaflets and led to the lowered valve performance.There is no indication of a product quality issue with regards to manufacture design or labeling.

• Brand Name: EPIC PLUS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16218281
• MDR Text Key: 307833639
• Report Number: 2135147-2023-00243
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067033086
• UDI-Public: 05415067033086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E200-29M
• Device Catalogue Number: E200-29M
• Device Lot Number: BR00032744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other